DEXAMETHASONE 3.3 MG/ML SOLUTION FOR INJECTION OR INFUSION

Transcript

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Dexamethasone 3.3 mg/ml solution for injection of infusion
Important information about this medicine
• Dexamethasone is a steroid medicine, prescribed for many diﬀerent conditions including serious illnesses
• You need to take it regularly to get the maximum benefit
• Don’t stop taking this medicine without talking to your doctor. You may need to reduce the dose gradually
• Dexamethasone can cause side effects in some people (read Section 4: Possible side eﬀects). Some problems such as mood changes
(feeling depressed, or ‘high’), or stomach problems can happen straight away. If you feel unwell, in any way, keep taking your medicine, but
see your doctor straight away
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read
Section 4 for more information)
• If you take it for more than 3 weeks, in the UK, you will be given a blue ‘steroid card’: always keep it with you and show it to any
doctor or nurse treating you
• Keep away from people who have chicken pox or shingles if you have never had them. They could aﬀect you severely. If you do come
into contact with chicken pox or shingles, see your doctor straight away
Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, pharmacist or nurse
• If you get any side eﬀects, talk to your doctor, pharmacist or nurse.
This includes any possible side eﬀects not listed in this leaflet. See
section 4.
What is in this leaflet:
1. What Dexamethasone is and what it is used for
2. What you need to know before you are given Dexamethasone
3. How you are given Dexamethasone
4. Possible side eﬀects
5. How to store Dexamethasone
6. Contents of the pack and other information

1. WHAT DEXAMETHASONE IS AND WHAT IT IS USED FOR
The name of your medicine is Dexamethasone 3.3 mg/ml Solution for
Injection or Infusion (called ‘Dexamethasone’ in this leaflet). It belongs
to a group of medicines called corticosteroids. Corticosteroids are
hormones that are found naturally in your body that help to keep you
healthy and well. Boosting your body with extra corticosteroid, such as
Dexamethasone, is an eﬀective way to treat various illnesses involving
inflammation in the body. Dexamethasone lowers inflammation,
which could otherwise go on making your condition worse. You must
take this medicine regularly to get maximum benefit from it.
Dexamethasone can be used to:
• Reduce inflammation
• Treat a number of diﬀerent diseases of the immune system

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
DEXAMETHASONE
You should NOT be given Dexamethasone if:
• You are allergic (hypersensitive) to dexamethasone or any other
ingredients in this medicine (listed in Section 6). The signs of an
allergic reaction include a rash, itching or shortness of breath
• You have an infection that aﬀects the whole body
• You have an infection of a joint
• You have unstable joints. This is a condition where joints, such as the
knee, can suddenly give way.
If any of the above apply to you, talk to your doctor, pharmacist or
nurse before being given Dexamethasone.
Check with your doctor first if:
• You have ever had severe depression or manic depression (bipolar
disorder).
This includes having had depression before while taking steroid
medicines like Dexamethasone
• Any of your close family has had these illnesses
If either of these applies to you, talk to your doctor, pharmacist or
nurse before being given Dexamethasone.
Mental problems while having Dexamethasone
Mental health problems can happen while having steroids like
Dexamethasone (see also Section 4: Possible side eﬀects).
• These illnesses can be serious
• Usually they start within a few days or weeks of starting the medicine
• They are more likely to happen at high doses
• Most of these problems go away if the dose is lowered or the
medicine is stopped. However, if problems do happen, they might
need treatment
Talk to a doctor if you (or someone taking this medicine), show any
signs of mental problems. This is particularly important if you are
depressed, or might be thinking about suicide.
In a few cases, mental problems have happened when doses are being
lowered or stopped.

Take special care with Dexamethasone
Before you are given Dexamethasone, tell your doctor if:
• You have a cancer of the blood because you may be at risk of a very
rare, potentially life-threatening condition resulting from a sudden
breakdown of tumour cells
• You have kidney or liver problems
• You have high blood pressure or heart disease
• You have diabetes or there is a family history of diabetes
• You have thinning of the bones (osteoporosis), particularly if you are
a female who has been through the menopause
• You have had muscle weakness with this or other steroids in the past
• You have raised eye pressure (glaucoma) or there is a family history
of glaucoma
• You have a stomach (peptic) ulcer
• You have mental problems or you have had a mental illness which
was made worse by this type of medicine such as ‘steroid psychosis’
• You have epilepsy
• You have migraines
• You have an infection with parasites
• You have tuberculosis (TB)
• You have stunted growth
• You have ‘Cushing’s syndrome’
• You have had a head injury
• You have had a stroke
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before having Dexamethasone.
More important information about having this kind of
medicine
If you develop an infection while you are having this medicine, you
should talk to your doctor. Please tell any doctor, dentist or person who
may be giving you treatment that you are currently taking steroids or
have taken them in the past.
If you are living in the UK, you should always carry a blue ‘steroid card’
which gives clear guidance on the special care to be taken when you
are taking this medicine. Show this to any doctor, dentist or person
who may be giving you treatment. Even after your treatment has
finished you must tell anyone who is giving you treatment that you
have taken steroids in the past.
Do not use Dexamethasone for the treatment of Acute Respiratory
Distress Syndrome (ARDS; a serious lung disease) if you have been
diagnosed with this condition for over 2 weeks.
Dexamethasone and viral infections
While you are having this kind of medicine, you should not come into
contact with anyone who has chicken pox, shingles or measles if you
have not had these illnesses. This is because you may need specialist
treatment if you get these diseases. If you think you may have had
exposure to any of these diseases, you should talk to your doctor
straight away. You should also tell your doctor if you have ever had
infectious diseases such as measles or chicken pox and if you have had
any vaccinations for these conditions in the past.
Please tell a doctor or anyone giving you treatment, such as at a
hospital, if:
• You have an accident
• You are ill
• You need any surgery. This includes any surgery you may have at your
dentist’s
• You need to have a vaccination
If any of the above apply to you, you should tell your doctor or the
person treating you even if you have stopped having this medicine.
If a child is having this medicine, it is important that the doctor
monitors their growth and development regularly. Dexamethasone
should not be routinely given to premature babies with respiratory
problems.

INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended for medical or
healthcare professionals only

daunorubicin, doxorubicin and vancomycin and should not be admixed
with solutions containing these drugs. It is also incompatible with
doxapram hydrochloride and glycopyrrolate in a syringe.
Dexamethasone Solution for Injection may be administered
Instructions for use and handling
intravenously, subcutaneously, intramuscularly, by local injection or as Dexamethasone can be diluted with the following infusion fluids:
a rectal drip.
sodium chloride 0.9%
Dexamethasone is a clear, colourless to slightly yellowish liquid. The
anhydrous glucose 5%
change of appearance of the solution from clear to yellowish is not a
invert sugar 10%
sign of deterioration of the product.
sorbitol 5%
ringer's solution
Incompatibilities
ringer-lactate
Dexamethasone (as sodium phosphate) is physically incompatible with dextran 40 10%w/v

Other medicines and Dexamethasone
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines you buy without a
prescription, including herbal medicines. Other medicines can aﬀect
the way Dexamethasone works or Dexamethasone can aﬀect the way
they work. In particular:
• Medicines to treat heart and blood problems, such as warfarin, high
blood pressure medicine, and water tablets (diuretics)
• Antibiotics such as rifampicin and rifabutin
• Medicines to treat epilepsy, such as phenytoin, carbamazepine,
phenobarbitone and primidone
• Medicines that control pain or lower inflammation, such as aspirin or
phenylbutazone
• Medicines used to treat diabetes
• Medicines used to lower potassium levels
• Medicines used to treat myasthenia
• Anti-cancer treatments, such as aminoglutethimide
• Ephedrine used to relieve symptoms of a blocked nose
• Acetazolamide used for glaucoma
• Carbenoxolone sometimes used for ulcers
Pregnancy and breast-feeding
Talk to your doctor before having this medicine if you are pregnant,
planning to become pregnant or are breast-feeding.
Driving and using machines
Dexamethasone is not likely to aﬀect you being able to drive or use any
tools or machines.
Important information about some of the ingredients
This medicine contains less than 1 mmol sodium per ampoule (less
than 23 mg per ampoule), i.e. it is essentially sodium free.

3. HOW YOU ARE GIVEN DEXAMETHASONE
Dexamethasone is normally given by a doctor. It will be given as an
injection into a muscle or under your skin. It can also be given as an
injection into a vein. The dose depends on your illness and how bad it
is. The dose in adults is normally from 0.5 to 24mg daily, and in
children 0.2 to 0.4mg/kg daily. Your doctor will decide the dose.
If you are given more Dexamethasone than you should
If you think you have been given too much Dexamethasone, tell your
doctor straight away. The following eﬀects may happen:
• Swelling of the throat
• Skin reaction
• Diﬃculty breathing
Effects when treatment with Dexamethasone is stopped
It can be dangerous to stop having this medicine suddenly. If you need
to stop this treatment, follow your doctor’s advice. He or she may tell
you to lower the amount of medicine you are having gradually until
you stop having it altogether. If you stop having this medicine too
quickly, your condition may get worse.
You may also feel a ‘withdrawal symptom’. These may include
headache, problems with your vision (including pain or swelling in the
eye), feeling or being sick, fever, pain in your muscles and joints,
swelling in the inside of your nose, weight loss, itchy skin and
conjunctivitis.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Dexamethasone can cause side eﬀects, although
not everybody gets them.
Dexamethasone can also cause side eﬀects when you stop using it.
• See Section 3, 'If you stop having Dexamethasone'
Serious side effects: tell a doctor straight away
Steroids including Dexamethasone can cause serious mental health
problems. These are common in both adults and children. They can
aﬀect about 5 in every 100 people taking medicines like
Dexamethasone. These include:
• Feeling depressed, including thinking about suicide
• Feeling high (mania) or moods that go up and down
• Feeling anxious, having problems sleeping, diﬃculty in thinking or
being confused and losing your memory
• Feeling, seeing or hearing things that do not exist. Having strange
and frightening thoughts, changing how you act or having feelings
of being alone
If you notice any of these problems, talk to a doctor straight away.
If you have an allergic reaction to Dexamethasone see a doctor
straight away
An allergic reaction may include:
• Any kind of skin rash or itching of the skin
• Diﬃculty in breathing or collapse.

Using these infusion fluids, Dexamethasone Injection can also be
injected into the infusion line without causing precipitation of the
ingredients. Direct injection into the infusion line is also possible with
mannitol 10%.
For single use only.
Discard any unused contents. Medicines should not be disposed of via
wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will help to protect
the environment.

If you get any of the following side effects see your doctor as
soon as possible:
• Stomach and gut problems: stomach ulcers which may perforate
or bleed, indigestion, having more of an appetite than usual,
diarrhoea, feeling or being sick
• Inflamed pancreas: this may cause severe pain in the back or
tummy
• Problems with salts in your blood such as too much sodium or
low potassium or calcium. You may have water retention
• Heart and blood problems: high blood pressure, blood clots
• Bone problems: thinning of the bones (osteoporosis) with an
increased risk of fractures, bone disease, damaged tendons, damage
to the joint where the injection was given
• Recurring infections that get worse each time such as chicken pox.
Also, thrush
• Skin problems: wounds that heal more slowly, bruising, acne,
sweating more than usual. Burning, redness and swelling where the
injection was given. This does not last long
• Eye problems: increased pressure in the eye including glaucoma,
eye disorders such as cataracts, eye infections
• Hormone problems: irregular or missing periods, stunted growth
in children and teenagers, swelling of the face (called a ‘Cushingoid’
or ‘moon’ face), it may aﬀect your diabetes and you may notice you
start needing higher doses of the medicine you take for diabetes,
your body may not be able to respond normally to severe stress such
as accidents, surgery or illness, growth of extra body hair
(particularly in women), increased appetite or weight gain
• Nervous system problems: fits or epilepsy may become worse,
severe unusual headache with visual problems, being unable to
sleep, feeling depressed, extreme mood swings, schizophrenia has
become worse, headache or problems with your vision (including eye
pain or swelling)
Reporting of side eﬀects
If you get any side eﬀects, talk to your doctor, pharmacist or nurse. This
includes any possible side eﬀects not listed in this leaflet. You can also
report side eﬀects directly via the Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard.
By reporting side eﬀects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE DEXAMETHASONE
• Keep this medicine out of sight and reach of children
• Do not store above 25°C
• Do not refrigerate or freeze
• Store in the original package in order to protect from light
• Do not use this medicine after the expiry date which is stated on the
carton and ampoule after “Exp.”. The expiry date refers to the last
day of that month
• Do not use this medicine if you notice damages to the glass ampoule
• Do not throw away any medicine via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. FURTHER INFORMATION
What Dexamethasone contains
• The active ingredient is dexamethasone sodium phosphate. Each ml
contains 3.3 mg dexamethasone as the sodium phosphate. Each 2 ml
contains 6.6 mg dexamethasone as the sodium phosphate
• The other ingredients are creatinine, ascorbic acid (E300), water for
injection, sodium hydroxide (E524), sodium citrate (E331).
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge: 0800 198 5000 (UK Only). Please be
ready to give the following information:
Product name
Reference number
Dexamethasone 3.3 mg/ml
PL 29831/0667
solution for injection of infusion
This is a service provided by the Royal National Institute of Blind
People
What Dexamethasone looks like and contents of the pack
Dexamethasone is a clear, colourless to slightly yellowish liquid. It
comes in 1 ml ampoules in packs of 5 or 10, and in 2ml ampoules in
packs of 5.
The Marketing authorisation holder is:
Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK
The Manufacturer is:
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
This leaflet was last revised in 02/2015

In-use storage precautions
Chemical and physical in-use stability has been demonstrated for 24 h
at room temperature and in daylight conditions when diluted with the
above infusion fluids.
From a microbiological point of view, the product should be used
immediately after dilution. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2-8°C, unless dilution
has taken place in controlled and validated aseptic conditions.
107400/1

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.